NCT01833949

Brief Summary

The objective of our study was to compare the efficiency of the right ULOD using thermal doses adjusted to ovarian volume (60 J/cm3) with the BLOD method at constant dose and to assess treatment efficiency.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

3.3 years

First QC Date

April 10, 2013

Last Update Submit

April 13, 2013

Conditions

PCOS

Keywords

polycystic ovary syndrome,laparoscopic ovarian drilling

Outcome Measures

Primary Outcomes (1)

  • Ovulation rate

    The main output parameter study is the difference in the rate of ovulation after LOD between the groups with respect to the input parameters (anti-Müller hormone AMH \[ng / ml\], free androgen index (FAI), T \[nmol / L\],luteinizing hormone (LH) \[IU / L\], androstenedione A \[nmol / L\], the number of follicles in both ovaries (AFC), total ovarian volume \[cm3\], the volume of the right ovary \[cm3\], the volume of the left ovary \[cm3\] and received thermal doses)

    Six menstrual cycles after LOD for each women

Secondary Outcomes (1)

  • Pregnancy

    Six menstrual cycles after LOD for each women

Other Outcomes (1)

  • Ovarian reserve

    Six menstrual cycles after LOD for each women

Study Arms (2)

ULOD arm (N=49)

ACTIVE COMPARATOR

Unilateral laparoscopic drilling In the ULOD group, we treated the right ovary.The thermal dose of 60 J applied per one cubic centimeter of ovarian volume was calculated from the mean total energy applied on a 10 cm3 ovary (627 J) from three earlier ULOD reports. Ovarian volume had been measured by ultrasound at baseline to determine the total thermal dose to apply on the right ovary. The number of punctures (Np) was also calculated for each patient according to the following formula: Np = 627 J / 30 W / 4 s Therefore, patients in the ULOD group differed in the number of punctures and energy received by the right ovary, depending on its volume.

Procedure: Unilateral laparoscopic drilling

BLOD arm (N=47)

ACTIVE COMPARATOR

Bilateral laparoscopic drilling In the comparator, BLOD group, all patients received 600 J per ovary (totaling 1200 J) through five punctures at 30 W for 4 s each (5 punctures x 4 s x 30 W = 600 J). The ovaries in both groups were cooled after the drilling by irrigating the abdominal cavity with 200-300 mL of physiological saline.

Procedure: Bilateral laparoscopic drilling

Interventions

Unilateral laparoscopic drillingPROCEDURE

Unilateral laparoscopic drilling with diathermy adjusted to ovarian volume

ULOD arm (N=49)
Bilateral laparoscopic drillingPROCEDURE

Bilateral laparoscopic drilling with fixed doses energy

BLOD arm (N=47)

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age between 25 and 35 years,
  • BMI\<30 kg/m2,
  • infertility period 1-3 years,
  • normal partner's semen findings,
  • LH≥10 or LH:FSH ratio ≥2,
  • testosterone \>2.5 nmol/L,
  • FAI\>4,
  • normal oral glucose tolerance test (OGTT).

You may not qualify if:

  • adrenal hyperplasia,
  • thyroid disease,
  • Cushing's syndrome,
  • hyperprolactinemia,
  • tumor-related androgen excess

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital Center Split

Split, Dalmatia, 21000, Croatia

Location

Related Publications (2)

  • Sunj M, Canic T, Jeroncic A, Karelovic D, Tandara M, Juric S, Palada I. Anti-Mullerian hormone, testosterone and free androgen index following the dose-adjusted unilateral diathermy in women with polycystic ovary syndrome. Eur J Obstet Gynecol Reprod Biol. 2014 Aug;179:163-9. doi: 10.1016/j.ejogrb.2014.05.011. Epub 2014 Jun 2.

    PMID: 24965999DERIVED

  • Sunj M, Canic T, Baldani DP, Tandara M, Jeroncic A, Palada I. Does unilateral laparoscopic diathermy adjusted to ovarian volume increase the chances of ovulation in women with polycystic ovary syndrome? Hum Reprod. 2013 Sep;28(9):2417-24. doi: 10.1093/humrep/det273. Epub 2013 Jul 2.

    PMID: 23820423DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Martina MS Šunj, dr.med

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr.med

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 17, 2013

Study Start

September 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

CR(1)